Bone Enhanced Ultrasound (BEUS) Data Library Development Project

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQueen's University

About this trial

A common treatment for low back pain involves fluoroscopy-guided spinal facet joint injections and/or medial branch nerve blocks. Unfortunately, fluoroscopy requires expensive equipment and personnel and exposes patients and healthcare providers to ionizing radiation. Ultrasound offers a safer, lower-cost alternative, but the traditional 2-dimensional (2D) ultrasound systems are limited due to poor image quality, particularly in patients with higher body mass index (BMI).

As an alternative, a novel Bone Enhanced Ultrasound (BEUS) technology uses artificial intelligence (AI) to create real-time 3-dimensional (3D) images of the spine to guide needle placement for these injections. The AI software is trained by overlaying computed tomography (CT) and ultrasound images from a patient dataset to recognize anatomical landmarks. BEUS aims to ultimately replace fluoroscopy for spinal injections, reducing radiation exposure, lowering healthcare costs, and improving accessibility, especially in rural settings where CT and fluoroscopy are unavailable.

A key limitation, however, is that the current AI system is trained based primarily on patients (mostly pediatric) undergoing perioperative assessment of scoliosis. To address this, the current study aims to develop a new, more clinically relevant training AI dataset by collecting spinal ultrasounds from up to 100 adult participants (most/all of whom are followed at the local chronic pain clinic for low back pain) with existing spinal CT or magnetic resonance imaging (MRI) scans. This dataset will be used to retrain the current AI model to enhance the accuracy of 3D spinal reconstructions, thereby improving the clinical relevance of the BEUS system.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individuals who have had previous CT or MRI scans of their spine in the past 5 years

Disqualifiers

< 18 years old

Trial population

Adults who have had previous CT or MRI scans of their spine in the past 5 years

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • spinal ultrasound

    Diagnostic test

    Coronal, axial, sagittal scans of the spine using ultrasound

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Study group1 intervention

Trial outcomes

Primary outcomes

1

Accuracy of 3D ultrasound spine reconstruction in adults with chronic low back pain

Time frame
From enrollment to end of US scan (30 days)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: